Luo Ning, Zeng Yi-Chen, Fu Bai-Tian, Low Je Wie, Fang Jian-Qiao
The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People's Republic of China.
Institute of International Education of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People's Republic of China.
J Pain Res. 2024 Aug 23;17:2727-2739. doi: 10.2147/JPR.S472648. eCollection 2024.
Diabetic peripheral neuropathy (DPN) affects patients' quality of life significantly. To date, selecting the appropriate treatment remains challenging. While electroacupuncture (EA) has shown promise as an effective adjunct therapy for DPN, and infrared thermography (IRT) has been considered as a potential predictor of treatment efficacy, the evidence for both remains inconclusive. As such, the objectives of this trial are twofold: to ascertain the efficacy of EA for DPN, and to explore the feasibility of IRT as an adjunctive objective tool for efficacy assessment.
The study was designed as a randomized, parallel, controlled trial. It spanned over 6 weeks of treatment and an additional 4 weeks of follow-up. 104 eligible participants will be stratified for severity of disease: mild with Toronto clinical scoring system(TCSS) score 6-8, moderate (TCSS score 9-11), and severe (TCSS score 12-19), and each level will be randomised in a 1:1 ratio into a EA group and waiting-list group. The waiting-list group received only the current conventional medication, while the EA group received an additional 12 EA sessions on top of the conventional medication. The primary outcome indicators is nerve conduction velocity (NCV), which will be tested at the baseline and week 6. Total clinical efficiency, TCSS, Clinical symptoms score of Traditional Chinese Medicine (TCM), Patient global impression of change(PGIC), Temperature of regions of interest (ROIs), and Physico chemical examination will be used as secondary outcome indicators. In addition, safety assessment will be determined based on adverse events during the trial.
The expected results of this study will determine whether EA improves efficacy in the treatment of DPN with an acceptable safety profile, and investigating variations in the efficacy of EA across different levels of DPN severity. Furthermore, it will explore the viability of IRT as an objective measure for evaluating treatment effectiveness for DPN.
ClinicalTrials.gov identifier, NCT06054087.
糖尿病周围神经病变（DPN）严重影响患者的生活质量。迄今为止，选择合适的治疗方法仍然具有挑战性。虽然电针（EA）已显示出作为DPN有效辅助治疗方法的前景，并且红外热成像（IRT）被认为是治疗效果的潜在预测指标，但两者的证据仍不确凿。因此，本试验的目标有两个：确定EA对DPN的疗效，并探索IRT作为疗效评估辅助客观工具的可行性。
本研究设计为随机、平行、对照试验。治疗为期6周，另有4周的随访期。104名符合条件的参与者将根据疾病严重程度分层：轻度（多伦多临床评分系统（TCSS）评分为6 - 8）、中度（TCSS评分为9 - 11）和重度（TCSS评分为12 - 19），每个级别将按1:1的比例随机分为EA组和等待名单组。等待名单组仅接受当前的常规药物治疗，而EA组在常规药物治疗的基础上额外接受12次电针治疗。主要结局指标是神经传导速度（NCV），将在基线和第6周进行测试。总临床有效率、TCSS、中医临床症状评分、患者整体变化印象（PGIC）、感兴趣区域（ROIs）温度和理化检查将用作次要结局指标。此外，将根据试验期间的不良事件进行安全性评估。
本研究的预期结果将确定EA是否能在可接受的安全性范围内提高DPN的治疗效果，并研究EA在不同DPN严重程度水平上疗效的差异。此外，它将探索IRT作为评估DPN治疗效果的客观指标的可行性。
ClinicalTrials.gov标识符，NCT06054087。
